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Orally disintegrating tablet of which stability of main drug is improved by using composite calcium salt and preparation method of orally disintegrating tablet

An orally disintegrating tablet and stability technology, which is applied in the field of medicine and its preparation, can solve the problems of difficult control of oxidized impurities, increased packaging cost and the like

Pending Publication Date: 2020-06-30
左人杰
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The problem of increased oxidized impurities is particularly prominent for some orally disintegrating tablet preparations (for example, vardenafil hydrochloride orally disintegrating tablets have a greater limit of oxidized impurities than ordinary tablets, that is, the existing orally disintegrating tablet technology makes it more difficult to control oxidized impurities )
The way to solve the oxidation of active ingredients in the existing technology is mainly to add antioxidants and use better packaging materials. At present, the use of antioxidants is still controversial in terms of safety, and the use of better packaging materials will double the cost. The increased packaging cost

Method used

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  • Orally disintegrating tablet of which stability of main drug is improved by using composite calcium salt and preparation method of orally disintegrating tablet
  • Orally disintegrating tablet of which stability of main drug is improved by using composite calcium salt and preparation method of orally disintegrating tablet
  • Orally disintegrating tablet of which stability of main drug is improved by using composite calcium salt and preparation method of orally disintegrating tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] The composition and dosage of the prescription are as follows:

[0088] Element Prescription amount (mg) Aripiprazole 10 calcium carbonate 47 calcium phosphate 47 Croscarmellose Sodium 29 colloidal silica 5 aspartame 3 Citric acid monohydrate 2 mint flavor 1 Sodium rigid fumarate 3 Magnesium stearate 3 gross weight 150

[0089] The preparation method is as follows:

[0090] (1) Take the above-mentioned prescription amount of aripiprazole, calcium carbonate, calcium phosphate, croscarmellose sodium, colloidal silicon dioxide and aspartame and pass through a 40-mesh sieve to obtain the first mixed powder;

[0091] (2) Take by weighing the above-mentioned prescription amount essence and citric acid monohydrate and pass through a 60 mesh sieve altogether to obtain the second mixed powder;

[0092] (3) After mixing the first mixed powder prepared in step (1) and the second mixed powder prepared...

Embodiment 2

[0099] The composition and dosage of the prescription are as follows:

[0100] Element Prescription amount (mg) Aripiprazole 10 calcium carbonate 40 calcium phosphate 40 Crospovidone 40 colloidal silica 8 sodium saccharin 5 Citric acid monohydrate 3 cherry flavor 2 Sodium rigid fumarate 4 Magnesium stearate 4 gross weight 156

[0101] The preparation method is as follows:

[0102] (1) Take the above-mentioned prescription amount of aripiprazole, calcium carbonate, calcium phosphate, crospovidone, colloidal silicon dioxide and sodium saccharin and pass through a 40-mesh sieve to obtain the first mixed powder;

[0103] (2) Take the above-mentioned prescription amount essence and pass through a 60-mesh sieve to obtain the second mixed powder;

[0104] (3) After mixing the first mixed powder prepared in step (1) and the second mixed powder prepared in step (2) for 15 minutes, pass through a 30-mesh s...

Embodiment 3

[0111] The preparation method of embodiment 3 orally disintegrating tablet is the same as embodiment 1, and prescription composition and consumption thereof are as follows:

[0112] Element Prescription amount (mg) Aripiprazole 10 calcium carbonate 60 calcium phosphate 60 Croscarmellose Sodium 25 colloidal silica 3 aspartame 1 Citric acid monohydrate 1 mint flavor 0.5 Sodium rigid fumarate 2 Magnesium stearate 2 gross weight 164.5

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PUM

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Abstract

The invention provides an orally disintegrating tablet of which the stability of a main drug is improved by using composite calcium salt. The orally disintegrating tablet comprises a main drug and auxiliary materials, the main drug comprises easily oxidized active components, and the auxiliary materials comprise composite calcium salt. The preparation method mainly comprises the following steps: 1) repeatedly sieving and mixing the main drug and the auxiliary materials for multiple times; and 2) tabletting. According to the present invention, the calcium salt with a specific ratio is added soas to significantly reduce the impurity generation of the easily-oxidized drug during the storage process, and the mixed powder has characteristics of good compressibility and low friability. A dry mixing direct pressing process is adopted, the process is simple, the product quality is stable and controllable, no antioxidant is added, and no additional cost is increased.

Description

technical field [0001] The invention relates to a medicine and a preparation method thereof, in particular to an orally disintegrating tablet, that is, an orally disintegrating tablet and a preparation method thereof. Background technique [0002] Orally disintegrating tablets refer to tablets that disintegrate or dissolve rapidly in the oral cavity without the need for water. —Generally suitable for small doses of raw materials, often used for patients who have difficulty swallowing or who do not cooperate with medication. It can be prepared by direct compression and freeze-drying. Orally disintegrating tablets should disintegrate or dissolve quickly in the oral cavity, have a good taste, be easy to swallow, and have no irritation to the oral mucosa. [0003] Aripiprazole orally disintegrating tablets were applied for marketing in the United States by OTSUKA in 2006, under the trade name ABILIFY. For the treatment of schizophrenia. Oxidation impurities in aripiprazole t...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/02A61K47/38A61K47/04A61K47/12A61K31/496A61K31/53A61K31/551A61K31/445A61K31/519A61P25/18A61P15/10A61P25/24A61P25/28
CPCA61K9/0056A61K9/2009A61K9/2013A61K9/2054A61K31/445A61K31/496A61K31/519A61K31/53A61K31/551A61P15/10A61P25/18A61P25/24A61P25/28
Inventor 左人杰孙超
Owner 左人杰